Press Release

February 22, 2021
1 min read

FDA grants priority review to Jakafi for chronic GVHD


Press Release

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The FDA granted priority review to ruxolitinib for the treatment of adults and children aged 12 years or older with steroid-refractory chronic graft-versus-host disease, according to a manufacturer-issued press release.

The agency based the decision, in part, on data from the randomized phase 3 REACH3 study — presented in December at the virtual ASH Annual Meeting and Exposition — which included 329 patients (median age, 49 years; range, 12-76; 61% male) who underwent allogeneic hematopoietic stem cell transplant and developed moderate or severe chronic GVHD.

 The main entrance of FDA Building 1.
Source: Adobe Stock.

As Healio previously reported, patients who received ruxolitinib (Jakafi, Incyte) — an oral Janus kinase 1/2 inhibitor — demonstrated a higher overall response rate at week 24, the study’s primary endpoint, compared with patients who received best available therapy (49.7% vs. 25.6%; P < .0001).

Ruxolitinib also was associated with longer median failure-free survival (not reached vs. 5.7 months; HR = 0.37; 95% CI, 0.268-0.51) and greater improvement in modified Lee Symptom Score response rate (24% vs. 11%; OR = 2.62; 95% CI, 1.42-4.82).

“Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options,” Peter Langmuir, MD, group vice president of oncology targeted therapies at Incyte, said in the press release. "The acceptance of this supplemental new drug applications represents an important milestone for Incyte as we continue our work toward helping more people living with GVHD, particularly for those who do not respond to steroids. We look forward to working closely with the FDA to bring this innovative therapy to patients and to providing continued support to the GVHD community in the United States.”

Ruxolitinib received FDA approval in 2019 for the treatment of steroid-refractory acute GVHD among adults and children aged 12 year or older.